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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011738
Receipt No. R000013723
Scientific Title Efficacy of multifocal intraocular lens implantation for cataract patients
Date of disclosure of the study information 2013/09/12
Last modified on 2021/09/22

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Basic information
Public title Efficacy of multifocal intraocular lens implantation for cataract patients
Acronym Efficacy of multifocal iontraocular lens
Scientific Title Efficacy of multifocal intraocular lens implantation for cataract patients
Scientific Title:Acronym Efficacy of multifocal iontraocular lens
Region
Japan

Condition
Condition Cataract
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate near and far postoperative visual acuity, satisfaction after multifocal intraocular lens implantation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes intra and postoperative complication
postoperative non-corrected visual acuity
(near, far, refraction)
satisfuction
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 implantation of multifocal intraocular lens after cataract removal
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
50 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria cataract patients who understand the contents of this study
Key exclusion criteria patients with another ocular diseases exept cataract
patients with corneal astigmatism over than -0.5D
patients who cannot understand the efficacy and disadvantage of multifocal intraocular lens
patients judged as inadequate for the participents
Target sample size 35

Research contact person
Name of lead principal investigator
1st name Koh-Hei
Middle name
Last name Sonoda
Organization Yamaguchi University
Division name Department of Ophthalmology
Zip code 7558505
Address 1-1-1 Minami-Kogushi, Ube City
TEL 0836-22-2278
Email sonodak@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name Naoyuki
Middle name
Last name Morishige
Organization School of Medicine
Division name Ophthalmology
Zip code 7558505
Address 1-1-1 Minami-Kogushi
TEL 0836-22-2278
Homepage URL
Email morishig@yamaguchi-u.ac.jp

Sponsor
Institute Department of Ophthalmology, Yamaguchi University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Ophthalmology, Yamaguchi University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Center For Clinical Research. Yamaguchi University Hospital
Address 1-1-1Minami-Kogushi, Ube city, Yamaguchi prefecture
Tel 0836-22-2428
Email me223@yamaguchi-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2013 Year 09 Month 12 Day

Related information
URL releasing protocol none
Publication of results Unpublished

Result
URL related to results and publications none
Number of participants that the trial has enrolled 7
Results For patients with a multifocal intraocular lens inserted, we listened to postoperative visual function such as distant, near and intermediate visual acuity and patient satisfaction.
We were able to examine the usefulness of multifocal intraocular lenses and the appropriateness of intraocular lens selection.
Results date posted
2021 Year 09 Month 21 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics Cataract patients
Participant flow 1.Surgery application
2.Cataract surgery
3.Postoperative evaluation
Adverse events none
Outcome measures visual acuity
Level of satisfaction
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 04 Month 10 Day
Date of IRB
2012 Year 04 Month 05 Day
Anticipated trial start date
2012 Year 08 Month 26 Day
Last follow-up date
2014 Year 02 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 09 Month 12 Day
Last modified on
2021 Year 09 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013723

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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